Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
ClinicalTrials.gov Identifier:
NCT00851864
First received: November 18, 2008
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.


Condition Intervention Phase
Venous Thromboembolism
Drug: Tinzaparin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Weight-Adjusted Dosing of Tinzaparin in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Rate of anti-Xa levels falling outside the target range of 0.4-1.2IU/mL [ Time Frame: anti-Xa level Day 1,28, then q4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean dosage requirement in each trimester [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • rate of clinical outcomes (PE/DVT) - objective testing of DVT/PE from radiology [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Women requiring therapeutic anticoagulation, singleton pregnancy,<30weeks
Drug: Tinzaparin

LMWH (tinzaparin-Innohep, Leo Pharma A/S) 175 anti-factor Xa units per kilogram of body weight sub-cutaneously once daily.

Treatment will be done for the duration of the pregnancy.

Other Name: innohep

Detailed Description:

Physicians in the Calgary Health Region are using tinzaparin (predominantly) and other low molecular weight heparins (LMWHs) for the treatment venous thromboembolism (VTE) in pregnancy. The most recent anticoagulation guidelines from American College of Chest Physicians (ACCP) suggest that heparin levels (anti-Factor-Xa activity levels) may be done periodically through pregnancy to determine the need to adjust the dose of LMWH as pregnancy progresses. This monitoring is widely practiced. There is no clear consensus in the literature, however, with some experts suggesting that initial and subsequent dosing may be done based on weight alone (as is done in the non-pregnant population). Given the multiple physiologic changes which occur to drug metabolism during pregnancy, this bears further evaluation. To date, there is very limited data on weight-adjusted dosing of LMWH in pregnancy. This study is therefore designed to determine if dosing of tinzaparin during pregnancy based on weight, with periodic weight-based adjustments, will result in adequate therapeutic anticoagulation.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancies in women over the age of 18 requiring anticoagulation for acute VTE (DVT/PE), or high-risk prophylaxis at a tinzaparin dose of 175 IU/kg.
  • High-risk patients include those with multiple (two or more) episodes of VTE and/or women receiving long-term anticoagulants (e.g. single event with known thrombophilia; APLAs and history of venous thrombosis)

Exclusion Criteria:

  • Multiple gestation\
  • Prosthetic valves
  • Active bleeding or other contraindication to anticoagulation therapy
  • Allergy to heparin, bisulfites, or fish, history of HIT (heparin induced thrombocytopenia), severe hypertension (diastolic >130)
  • Severe hepatic or renal failure
  • Patients over 100kg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851864

Locations
Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
LEO Pharma
Investigators
Principal Investigator: Paul Gibson, M.D. FRCPC University of Calgary
Study Chair: Kendra Newell, M.D. University of Calgary
Study Chair: David Sam, M.D. FRCPC University of Calgary
  More Information

Publications:
Responsible Party: Dr. Sue Ross, Adjunct Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00851864     History of Changes
Other Study ID Numbers: 05161977
Study First Received: November 18, 2008
Last Updated: August 14, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Calgary:
anticoagulation
pregnancy

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Tinzaparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014